MDR-TB Close Contacts Tracing in China (TCCT Study)

July 20, 2020 updated by: Wen-hong Zhang, Huashan Hospital

Multidrug Resistant Tuberculosis Close Contacts Tracing in China

To investigate the incidence of etiologically confirmed or clinically diagnosed active tuberculosis in close contacts of MDR-TB patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This study is a prospective observational cohort study. MDR-TB patients from multi-centers in China were continuously evaluated one by one, their close contacts were screened for elibgility. All subjects were followed for the same length of time: 80 weeks after enrollment. The symptoms and signs of tuberculosis were followed up to monitor the occurrence of tuberculosis.

The primary objective is to investigate the incidence of etiologically confirmed or clinically diagnosed active TUBERCULOSIS in close contacts of MDR-TB patients.

The secondary objective is to assess latent TB infection rates in close contacts of MDR-TB patients; evaluate the high risk factors of TUBERCULOSIS in close contact population; assess the loss rate of close contacts within 80 weeks; assess the 80-week mortality rate among close contacts; isolate the mycobacterium tuberculosis from all patients with active tuberculosis and analyze drug resistance to evaluate the homology and drug-resistant transmission pattern of Mycobacterium tuberculosis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangzhou
      • Shenzhen, Guangzhou, China
        • The Third People's Hospital of Shenzhen City
        • Contact:
    • Guizhou
      • Guizhou, Guizhou, China
        • Guiyang Public Health Treatment Center
        • Contact:
          • Cui Cai
          • Phone Number: 86+13885078936
    • Henan
      • Zhengzhou, Henan, China
        • Henan Hospital of Infectious Diseases
        • Contact:
          • Yu Chen
          • Phone Number: 86+15936200217
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Jiangxi Public Health Center
        • Contact:
          • Xinya Yuan
          • Phone Number: 86+13870963101
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital of Fudan University
        • Sub-Investigator:
          • Qiaoling Ruan
        • Sub-Investigator:
          • Lingyun Shao
        • Sub-Investigator:
          • Qingluan Yang
        • Sub-Investigator:
          • Feng Sun
        • Sub-Investigator:
          • Yang Li
    • Xinjiang
      • Ürümqi, Xinjiang, China
        • Chest Hospitalof Xinjiang Uygur Autonomous Region of PRC
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Hangzhou Red Cross Hospital
        • Contact:
      • Wenzhou, Zhejiang, China
        • The Central Hospital of Wenzhou City
        • Contact:
          • Xiangao Jiang
          • Phone Number: 86+13676788085

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population enrolled in this study is close contact of patients with MDR-TB

Description

The index patient:

Inclusion Criteria:

1.18-70 years old; 2.Has smear-positive pulmonary tuberculosis with initial laboratory results with resistance to rifampicin confirmed by GeneXpert; 3.Have an identifiable address and stay in the area during the study period.

Exclusion Criteria:

  1. Combined extrapulmonary tuberculosis;
  2. HIV antibody positive and AIDS patients;
  3. Critically ill patients, and according to the judgment of the research physician, it is impossible to survive for more than 4 months.

Termination/termination criteria:

  1. The patient requests to withdraw from the visit;
  2. Misdiagnosis and error.

The close contacts:

Inclusion Criteria:

  1. Willing to participate in trial treatment and follow-up and can give informed consent;
  2. Willing to carry out HIV testing;
  3. More than 6 hours of cohabitation per week in the 2 weeks prior to diagnosis of the index case.

Exclusion Criteria:

  1. Patients with active tuberculosis confirmed clinically or etiologically;
  2. Mental illness and severe neurosis;
  3. The researchers determined that there were any ineligible conditions.

Termination/termination criteria:

  1. The patient requests to withdraw from the visit;
  2. Find a violation of inclusion or exclusion criteria during treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Close contacts of MDR-TB patients
Close contacts of MDR-TB who met the inclusion and exclusion criteria were enrolled. Routine follow-up is scheduled at week 8, 20, 32, and 80. During the visit, participants with suspected tuberculosis symptoms will have detailed clincial assessent, weight measurement, sputum smear, sputum culture and drug sensitivity examination, imaging examinations, etc. For patients diagnosed with TB, the trial ends. Proper treatment will be started. For all paricipants who are not diagnosed with tuebrculosis in previous follow-up, the last follow-up of this study is all "face-to-face" visits. Sputum smear, sputum culture and chest imaging screening will be performed when necessary to exclude the possibility of tuberculosis infection. In addition, If the participants has suspected TB symptoms or is diagnosed with TB in another hospital, the researchers can be contacted for follow-up at any time.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Confirmed cases of active tuberculosis
Time Frame: 80 weeks after enter the group
Mycobacterium tuberculosis was indicated to be positive by etiology, and the positive ones were confirmed by molecular identification. A false positive may be determined if the investigator determines that the etiological diagnosis is inconsistent with the patient's clinical condition, or that the patient's symptoms, signs, or influence of the medical diagnosis has not responded to treatment.
80 weeks after enter the group
Clinical diagnosis of active tuberculosis
Time Frame: 80 weeks after enter the group
History, signs, imaging studies (mainly chest CT), or other diagnostic methods suggest objective evidence (cough, fever, night sweats, wasting, hemoptysis) for the diagnosis of tuberculosis, rather than other diseases.
80 weeks after enter the group

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of latent tuberculosis infection
Time Frame: at enrollment
Incidence of latent tuberculosis infection at enrollment
at enrollment
Risk factors associated with TB development
Time Frame: 80 weeks after enter the group
Risk factors associated with TB development among the close contact population
80 weeks after enter the group
Compliance of follow-up
Time Frame: 80 weeks after enter the group
number of participants who complete the follow-up schedule
80 weeks after enter the group
Comparison the Mycobacteria tuberculosis strains between index patients and their contacts
Time Frame: 80 weeks after enter the group
All Mycobacteria tuberculosis strains from index patients ans close contacts will be analyzed to explore the transmission pattern
80 weeks after enter the group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY2020-806

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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